Field of the Invention
This invention is directed to an assembly and method for performing the occlusion of a left atrial appendage of the heart and includes a delivery instrument having occlusion material movably connected thereto and disposable outwardly therefrom. The occlusion material comprises at least one elongated single strand of flexible material having sufficient flexibility to progressively form an arbitrarily intermingled array of occlusion material within the interior of the left atrial appendage as it is progressively fed therein in a manner which substantially fills and conforms to the interior configuration thereof.
Description of the Related Art
The left atrial appendage (LAA) is a muscular pouch connected to the left atrium of the heart. It functions as a reservoir for the left atrium but may present serious consequences or problems to the individual when blood pools therein. Such pooling of blood in the appendage may arise spontaneously or due to atrial fibrillation and may result in the formation of blood clots. Moreover, the exiting of the formed blood clot from the interior of the left atrial appendage into the blood stream can cause serious problems when they embolize in the arterial system. Importantly, embolization of these clots is a frequent cause of stroke. Accordingly, it is extremely important to prevent such blood clot formation and/or the migration of a formed clot from the interior of the left atrial appendage in order to reduce the possibility of stroke occurrence, especially in patients with atrial fibrillation.
One common method of reducing the risk of clot formation is the treatment of an individual with anticoagulants such as but not limited to Warfarin. While this method has been generally effective in reducing the occurrence of strokes in a treated patient, such strokes may still occur if there is a necessary or inadvertent lapse of treatment. An additional disadvantage or problem in the anticoagulant treatment is the fact that it is contraindicated in some patients. Another method of treatment in trying to reduce clotting and embolization leading to a stroke includes left atrial appendage obliteration. Obliteration procedures may occur during open cardiac surgery or, less invasively, during thoracoscopic procedure. However, it is recognized that numerous patients with a high risk of stroke are not candidates for such procedures because of a compromised status in their health.
Due to the disadvantages and problems with the above noted treatment procedures, extensive developmental advancements have been attempted with left atrial appendage occlusion. This is a treatment strategy which is directed to the prevention of blood clot formation within the interior of the left atrial appendage. Known occlusion procedures include the use of the “WATCHMAN device” manufactured by Atritech, Inc., of Plymouth Minn., which is intended for use in patients with non-valvular atrial fibrillation (AF), where heart surgery is a backup. Another device commonly termed “PLAATO” (Percutaneous Left Atrial Appendage Transcatether Occlusion) was generally recognized as the first left atrial appendage occlusion device. Both of the above noted LAA occlusion systems are introduced into the right atrium and are then passed into the left atrium through a patent formen ovale or through a puncture hole in the septum wall.
Known and/or recognized adverse events and limitations of the above noted procedures include pericardial effusion, incomplete LAA closure, dislodgment of the occluding device, blood clot formation on the device itself, requiring prolonged oral anticoagulation administration, as well as the general risks associated with catheter based techniques, such as air embolism.
Accordingly, there is a need in the medical arts for an effective procedure for overcoming the dangers associated with blood clot migration within the interior of the left atrial appendage. Such a proposed and improved treatment procedure should be reliable, safe and overcome the disadvantages and problems associated with known treatments of the type set forth above.